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DewDiligence

11/12/12 7:29 PM

#152212 RE: DewDiligence #152118

Actually, ABT is conducting seven all-oral phase-3 HCV trials for genotype-1 patients: the three I cited in #msg-81374289 and four others called SAPHIRE-III, SAPHIRE-IV, TURQUOISE-I, AND PEARL-II.

SAPHIRE-III and SAPHIRE-IV (unlike SAPHIRE-I and –II, where all patients receive ribavirin and the control arm is 12 weeks of full-fledged placebo) test 12 weeks of ABT’s 3-DAA combination +/- ribavirin. SAPHIRE-III is for treatment-naïve genotype-1b and SAPHIRE-IV is for treatment-naïve genotype-1a.

PEARL-II is a clone of SAPHIRE-III except that it is for treatment-experienced genotype-1b patients.

TURQUOISE-I tests HCV/HIV co-infected patients using 12- and 24-week arms of ABT’s 3-DAA cocktail + ribavirin.

All told, these phase-3 trials will have about 2,000 patients. (Source: Today’s AASLD CC.)